search
Back to results

Safety of PDT-Photofrin® Prior to Lung Surgery

Primary Purpose

Lung Cancer, Lung Cancer Metastatic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Porfimer Sodium
Fiber optic
Sponsored by
Concordia Laboratories Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring lung cancer, lung carcinoma, lung metastases

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 18-79
  • Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable
  • Candidate for surgical resection
  • Candidate for bronchoscopy
  • Tumor is accessible for unrestricted illumination of PDT
  • Subject is deemed likely to survive for at least 3 months
  • Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
  • Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
  • Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines & local requirements

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or carcinoid tumors
  • Primary or metastatic lung tumor located in central lung or near vertebral body
  • Tumor invades a major blood vessel
  • Presence of concurrent non-solid malignancy
  • Tumor previously treated with radiation therapy
  • Chemotherapy in the last four weeks
  • Tumor treated with PDT within the last 3 months
  • Abnormal blood results
  • Subject with porphyria or hypersensitivity to Photofrin
  • Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
  • Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
  • female who is breast-feeding or intends to breast-feed during study
  • subject who participated in another study within last 30 days or intends to participate in another study during this study

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of Colorado
  • Moffitt Cancer Center
  • Cancer Treatment Centers of America/Southeastern
  • AMITA Health Alexian Brothers Medical Center
  • Dubois Medical Center
  • UT MD Anderson Cancer Center
  • Providence Health & Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photodynamic therapy-Photofrin

Arm Description

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Outcomes

Primary Outcome Measures

Safety: Number of Participants With at Least One Adverse Event
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Safety evaluation will include incidence of skin photosensitivity summarized for each subject.

Secondary Outcome Measures

Macroscopic Tissue Examination
The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
ECOG Performance Status: Period 1 PDT Day 3
Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
ECOG Performance Status: Period II Surgery (Day 13-18)
Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
ECOG Performance Status: Period III Follow-up (Day 20-25)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
ECOG Performance Status: Period III Follow-up (Day 43 -48)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

Full Information

First Posted
November 13, 2017
Last Updated
December 30, 2019
Sponsor
Concordia Laboratories Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03344861
Brief Title
Safety of PDT-Photofrin® Prior to Lung Surgery
Official Title
A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concordia Laboratories Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.
Detailed Description
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location. Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction. The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Metastatic
Keywords
lung cancer, lung carcinoma, lung metastases

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photodynamic therapy-Photofrin
Arm Type
Experimental
Arm Description
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Intervention Type
Drug
Intervention Name(s)
Porfimer Sodium
Other Intervention Name(s)
Photofrin
Intervention Description
Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Intervention Type
Device
Intervention Name(s)
Fiber optic
Intervention Description
After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Primary Outcome Measure Information:
Title
Safety: Number of Participants With at Least One Adverse Event
Description
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Time Frame
108 days (to 3 months post surgery)
Title
Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Description
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time Frame
108 days (to 3 months post surgery)
Title
Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Description
Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Time Frame
108 days (to 3 months post surgery)
Title
Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Description
Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Time Frame
108 days (to 3 months post surgery)
Title
Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Description
Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Time Frame
108 days (to 3 months post surgery)
Secondary Outcome Measure Information:
Title
Macroscopic Tissue Examination
Description
The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Time Frame
Day 13 to 18
Title
Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
Description
The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
Description
The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
Description
The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
Description
The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
Description
The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
Description
The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
Description
The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Description
Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Description
Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Description
Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Description
Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Description
Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Description
Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame
Day 13 to 18
Title
Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Description
Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame
Day 13 to 18
Title
ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Description
Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
Baseline (-30 to -1 Days)
Title
ECOG Performance Status: Period 1 PDT Day 3
Description
Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
Day 3
Title
ECOG Performance Status: Period II Surgery (Day 13-18)
Description
Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
Day 13 to 18
Title
ECOG Performance Status: Period III Follow-up (Day 20-25)
Description
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
Day 20 to 25
Title
ECOG Performance Status: Period III Follow-up (Day 43 -48)
Description
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
Day 43 to 48
Title
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Description
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
108 days (to 3 months post surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18-79 Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable Candidate for surgical resection Candidate for bronchoscopy Tumor is accessible for unrestricted illumination of PDT Subject is deemed likely to survive for at least 3 months Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines & local requirements Exclusion Criteria: Diagnosis of small cell lung cancer or carcinoid tumors Primary or metastatic lung tumor located in central lung or near vertebral body Tumor invades a major blood vessel Presence of concurrent non-solid malignancy Tumor previously treated with radiation therapy Chemotherapy in the last four weeks Tumor treated with PDT within the last 3 months Abnormal blood results Subject with porphyria or hypersensitivity to Photofrin Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures female who is breast-feeding or intends to breast-feed during study subject who participated in another study within last 30 days or intends to participate in another study during this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin O'Neil
Organizational Affiliation
Concordia Laboratories Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cancer Treatment Centers of America/Southeastern
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
AMITA Health Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Dubois Medical Center
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Providence Health & Services
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a phase 2 study with only 10 subjects which is of minor use to other researchers.

Learn more about this trial

Safety of PDT-Photofrin® Prior to Lung Surgery

We'll reach out to this number within 24 hrs